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Completed

NCT Number: NCT01933217

Methylphenidate for Attention Problems After Pediatric TBI

Traumatic Brain Injury (TBI) - methylphenidate treatment

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Key information

Conditions

Traumatic Brain Injury ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurodevelopmental Disorders TBI Trauma, Nervous System Wounds and Injuries

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

The objectives of the study are to (1) determine the efficacy and dose-response of methylphenidate treatment of attention problems after pediatric traumatic brain injury (TBI) and (2) provide a better understanding of the relationship of a prior history of attention deficit hyperactivity disorder (ADHD), ADHD subtypes after TBI, executive function, and attentional control to treatment efficacy. The proposed clinical trial will enroll 50 children, age 6-17 years, with attention problems >6 months after moderate to severe TBI into a randomized, double-blind, placebo-controlled, cross-over design trial with 3 dose conditions (low, medium, and high).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between ages of 6-17
  • Sustained Moderate to Severe TBI
  • TBI occurred at least 6 months prior to beginning the study
  • TBI occurred no earlier than 5 years of age
  • Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or hyperactivity scale

Exclusion criteria

  • History of developmental disability or mental retardation
  • Current active participation in ADHD-related behavioral intervention
  • History of psychiatric condition requiring an inpatient admission in past 12 months
  • Actively taking medications with a contraindication to Concerta that cannot be discontinued
  • Current use of stimulant medication or ADHD specific medications that cannot be discontinued
  • Non-blunt head injury
  • Family history of arrhythmia
  • Pregnancy

Treatment and study plan

Methylphenidate

Drug

Other names: Concerta

Placebo

Drug

Primary outcomes

  1. Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS)

    Time frame: Reported at End of Methylphenidate Arm (Week 4 or 8)

    Changes in symptom ratings were assessed on the Vanderbilt ADHD parent rating scales (VADPRS). A measure of ADHD symptom severity (Total Symptom Score [TSS]) is computed by totaling the scores from items 1-18 (Inattentive +Hyperactive-impulse domains), with a rating of none=0, occasionally=1, often=2, very often=3, provided. Scores for inattentive and hyperactive-impulsive domains were generated by totaling the 9 symptoms in these domains, and a TSS was computed by totaling items across domains.

  2. Parent Outcome-Behavior Rating Inventory of Executive Functioning (BRIEF)

    Time frame: Reported at End of Methylphenidate Arm (Week 4 or 8)

    The Behavior Rating Inventory of Executive Functioning (BRIEF)-Parent was used to assess executive functioning behaviors. The global executive composite (GEC), behavior regulatory index (BRI), and metacognitive index (MI) T-scores were used, with higher scores reflecting poorer executive functioning. T-scores were normalized to 50 with a standard deviation of 10.

Secondary outcomes

  1. Neuropsychological Outcome- Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI)

    Time frame: Reported at End of Methylphenidate Arm (Week 4 or 8)

    The Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI) has been designed for children 6-16:11 years of age and provides a measure of processing speed. For this index scale, the average score is 100 with a standard deviation of 15. Higher scores reflect better processing speed. One participant was administered the Wechsler Adult Intelligence Scale 4th Edition Processing Speed Index (WAIS-IV-PSI). All scores were included in the combined WISC/WAIS processing speed variable since both measures yield highly correlated standard scores.

  2. Teacher Outcome Measure

    Time frame: January 1, 2014 - July 20, 2017

    Used to assess child behavior.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Efficacy of Methylphenidate for Management of Long-Term Attention Problems After Pediatric Traumatic Brain Injury (TBI)

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 2, 2013
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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